ES2610028T3 - Infusion set - Google Patents

Abstract

An infusion set comprising: a base (60) having upper and lower sides (92, 118), a base cannula (52) extending downwardly from the lower side (118), a flange (96) and an access point (62) extending upwards from the upper side (92), the access point (62) being in fluid communication with the base cannula (52), and the access point (62) comprising a partition (130) adapted to seal the lateral access point (62) from the fluid communication therethrough; an adhesive layer (50) mounted on the lower side (118) of the base (60); an introduction cover (64) adapted to be pressed against the upper side (92) of the base (60) and detachably fixed to the base (6), the introduction cover (64) comprising the upper and lower sides and a needle (66) extending downwards from the lower side, the needle (66) being adapted to extend through the partition (130) on the upper side of the base (60) and through the cannula (52) of the base on the lower side (118) of the base (60) and an infusion cover (54) comprising an upper side and a lower side, a coupling part (74) of the access point with a tubular wall ( 86) and barbed feet (94) adapted to engage the flange (96) of the base (60), the infusion cover (54) being detachably detachable from the base (60), the coupling part (74) to the access point with its tubular wall (86), which closely surrounds the access point (62) when the infusion cover (54) is attached to the base (60), the t being Infusion unit (54) adapted to rotate with respect to the base (60), while the infusion cover (54) comprises an infusion cannula (170) extending downwardly from the bottom side of the cover (54) of infusion, and a flexible elongated lumen (162) in fluid communication with the infusion cannula (170), the infusion cannula (170) being adapted to extend through the partition (130) on the upper side of the base ( 6) by attaching the infusion cover (54) and the base (60) to place the flexible lumen (162) and the infusion cover (54) in fluid communication with the base cannula (52), the wall (86) tubular of the coupling part (74) of the access point that surrounds and covers the end of the infusion cannula (170) with a vertical dimension (e) between an outlet (174) of the infusion cannula (170) and a lower edge (182) of the tubular wall (86) of the access point coupling part (74) and a vertical distance (h) between an upper edge the top of the barbed feet (94) and the bottom edge (182) of the tubular part (86) of the coupling part (74) to the access point.

Description

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DESCRIPTION

Infusion set

Background

Field of the Invention

The invention relates generally to the field of infusion equipment and more particularly to infusion equipment with removable injection needles.

Description of the related technique

Subcutaneous injection is a standard method for the administration of medication in a patient's body. To facilitate frequent or continuous subcutaneous injection of the medication, access points are often used for subcutaneous injection. Such access points for injection extend through the skin and may remain in place for several days. Currently, a main application of such access points for injection is to provide continuous supply of a medication, such as insulin, from portable pumps carried with the patient. When used with a portable pump, the access point for injection is usually connected to the pump through a fluid line. Another application of the access points for subcutaneous injection is to allow multiple injections of medication in a patient without the need to puncture the patient's skin again. In this application, the medication is injected from a standard medical instrument, such as a syringe, through a soft elastomer partition at the access point for the injection that supplies the medication subcutaneously.

Access points for subcutaneous injection generally require a sharp, rigid needle to pierce the patient's skin when they are initially attached to the patient. However, if the needle is left in place to provide the supply of the medication through the skin, after one or two days the needle would be uncomfortable for the patient. To solve this problem, infusion equipment with removable needles and soft plastic cannula have been developed to place inside a patient's body. However, these devices have many disadvantages. There is still a need for an improved infusion set that is less bulky, less susceptible to contamination, more comfortable for the user and easier to use.

US 2002/0095138 describes a system for subcutaneous administration in a patient's body of a fluid from a remote container. The main equipment of the system includes a rotating element. When the rotating element is perpendicular to the main equipment, the main equipment admits a handle and a needle for placement in a patient's body, but no fluid is infused into the patient's body. After removing the handle and the needle, the supply tube can be attached to the rotating element, which can then be rotated to a position along and adjacent to the patient's skin to allow infusion.

WO 02/070037 A2 describes an infusion hub assembly. The infusion hub assembly comprises a hub and a housing that can rotate with respect to the hub during infusion.

WO 02/081012 A2 describes a system for connecting a liquid supply line to a cannula. The system includes a foundation body and a plug. A protruding edge of the plug is first coupled with the foundation body, then the plug tilts down around the rotation point defined by said coupling to allow a liquid to flow from the plug to the foundation body.

US-A-5,545,143 describes an injection access point assembly for subcutaneous administration of medication. The assembly includes a molded body that has a soft cannula that extends downward from a flat bottom surface. A metal needle that penetrates through a septum and through a soft cannula lumen that is used to insert the cannula through the skin.

Summary

An embodiment of the present invention provides an infusion set comprising a base element, an introduction cover and an infusion cover. The base element preferably comprises an access point on its first side and a soft cannula extending from a second side of the base element. The access point is configured to be in fluid communication with the cannula. The access point also comprises a partition adapted to seal the access point against the flow of unwanted fluid. The introduction cover is adapted to be mounted on the base element and has a needle adapted to extend through the partition and said soft cannula in an assembled position. The infusion cap comprises a lumen adapted to receive an elongated flexible tube. The infusion cap also comprises a hard cannula adapted to be inserted through the partition and to place said soft cannula in fluid communication with said lumen.

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The base element is preferably circular and the access point preferably comprises a cylindrical part that extends from a first side of the base element. The introduction cover preferably comprises a hollow cylindrical part that extends from the second side of the introduction cover and is coaxially located with the introduction needle. The infusion cap preferably comprises a hollow cylindrical portion that extends from the second side of the infusion cap and is coaxially located with the hard cannula. Preferably, the first side of the infusion cover is dome-shaped and the infusion cover is preferably adapted to be rotatable with respect to the base element when the infusion cover and the base element are assembled.

The base is preferably surrounded by a flange adapted to couple and retain an external component. A cannula extends downward from a first side of said base; and an adhesive layer is secured to the first side of the base. A substantially cylindrical access point extends upward from a second side of said base. The access point comprises a partition configured to have a fluid path through it. The fluid path is preferably formed by a slit that extends through the partition, but alternatively the fluid path can be created by piercing the partition with a needle or other object. In a method of using an embodiment of the infusion set described herein, the base element is prepared for adherence to a patient's skin and the needle and cannula are inserted through the patient's skin. The introducer cap is disconnected and the needle is removed from the base element. The infusion cap is then mounted on the base element such that the infusion cap cannula is in fluid communication with the base cannula and the infusion cap is rotatable relative to the base element.

Brief description of the drawings

Having thus summarized the general nature of the invention, certain preferred embodiments and modifications thereof will be apparent to those skilled in the art from the detailed description in this document that referring to the figures below, of which:

Figure 1 is an exploded perspective view of an introduction assembly of an infusion set and base assembly having the desired characteristics and advantages.

Figure 2 is a top view of the introduction cover of Figure 1.

Figure 3 is a cross-sectional view of the introduction cover of Figure 1, taken through line 3-3.

Figure 4 is a cross-sectional view of the introduction cover of Figure 1, taken through line 4-4.

Figure 5 is a perspective view of the base element of Figure 1.

Figure 6 is a cross-sectional view of the base element of Figure 4.

Figure 7 is a perspective view of an assembled introducer and a base element.

Figure 8 is a cross-sectional view of the assembly of Figure 7 taken through line 8-8.

Figure 9 is a cross-sectional view of the assembly of Figure 7 taken through line 9-9.

Figure 10 is a top view of an infusion cap having the desired characteristics and advantages.

Figure 11 is a cross-sectional view of the infusion cap of Figure 10 taken through line 11-11.

Figure 12 is a perspective view of an assembly of an infusion cover and a base element.

Figure 13 is a cross-sectional view of the assembly of Figure 12 taken through line 13-13.

Figure 14 is a cross-sectional view of the assembly of Figure 12 taken through line 14-14.

Detailed description of the preferred embodiments

An infusion set having the desirable characteristics and advantages will now be described with reference to the attached figures. Although the following description is provided in the context of an infusion set for use with an insulin pump, the person skilled in the art will recognize that the characteristics of the present infusion set may also provide advantages in other applications.

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The infusion set illustrated in Figures 1-14 and described herein generally comprises a base assembly 20 adapted to detachably receive an introduction assembly 30 and an infusion assembly 40 (see Figure 13).

Figure 1 illustrates an exploded view of the components of the base assembly 20 and the introduction assembly 30. The base assembly 20 is generally configured to be fixed to a patient's skin by means of an adhesive layer 50 to keep a soft cannula 52 inside a patient and allow an infusion cap 54 (see Figures 10-14) to be mounted on the base assembly 20 to deliver a fluid through the cannula 52 and into a patient's body. The base assembly 20 preferably comprises a base element 60 with a soft cannula 52 extending from a first side of the base element 60, an access point 62 extending from a second side of the base element 60 and a layer 50 adhesive that can be secured to the second side of the base element 60.

The introduction assembly 30 is generally configured to detachably engage with the base assembly 20 to facilitate the introduction of the soft cannula 52 through the skin of a patient to a desired depth in the subdermal fatty tissue of the patient.

Figures 1-4 illustrate embodiments of an introduction assembly 30 comprising an introduction cover 64 and an introduction needle 66 extending downwardly from the cover 64. In the illustrated embodiment, the introduction cover 64 is generally in the form of dome and has a handle part 72, a coupling part 74 to an access point, a base coupling part 76 and release handles 100.

As illustrated, the handle portion 72 generally includes a flange with a needle clamping section 82 that extends through a central portion of the flange 72. In one embodiment, the introduction cap 64 is formed with a section 82 for securing the needle comprising a lumen in which an insertion needle 66 can be inserted and secured later. Alternatively, the introduction needle 66 may be molded into the material of the introduction cap 64 by any of a variety of overmolding procedures available to the person skilled in the art. According to one embodiment, the needle receiving section 82 extends partially into the cavity 84 of the coupling part 74 of the access point to provide an additional length along which the needle 66 will rest. supported needle length (ie, the length of the needle retained within the needle retention lumen 82) may vary as necessary for needles of various lengths. For example, in the case of a needle with a total length of about 1 ", a needle receiving section preferably has a length between about 3/16" and about 5/16 ".

The introduction needles can be provided in a variety of sizes as needed for a particular cannula or application. For example, needles with lengths of about 0.5 "to about 2" or more can be provided. In other alternative embodiments, needles outside these ranges may also be used as necessary. Additionally, an introducer needle can be solid, or it can have a hollow internal lumen, as desired.

The handle section 72 of the introduction cover 64 is illustrated to comprise a substantially flat section extending upwardly from the dome-shaped cover 64. The handle section 72 preferably has a substantially large surface such that a patient or caregiver can easily grasp the introduction cover 64 for assembly with the base element 60 and to insert the needle 66 into the patient. For example, as shown, the handle section may extend through a substantial part of the diameter of the introduction cap. The handle section 72 can also extend upwardly from the lid dome from about 0.2 "to about 1". In a preferred embodiment, the handle section 72 extends approximately ½ "above the top of the introduction cover 64. The person skilled in the art will recognize that the handle portion 72 can be shaped in another way and sized as desired. Alternatively, the introduction cap 30 may be held by the release handles 100 or any other convenient part during needle insertion as will be described further below.

As illustrated in Figure 2, the coupling part 74 of the access point preferably comprises a cylindrical section configured to closely surround the access point 62 of the base part 60 in an assembled position. The tubular wall 86 of the coupling part 74 of the access point is generally configured to come into contact with the upper surface 92 of the base element 60 as will be described further below. A narrow fit between the access point 62 and the tubular wall 86 of the coupling part 74 of the access point of the introduction cover 64 advantageously provides a minimum of movement of the base element 60 with respect to the introduction cover 64 during the introduction of needle 66 and catheter 52 into a patient.

In the illustrated embodiment, the base coupling portion 76 of the introduction lid 64 generally comprises a pair of wings 98 extending downwardly from the lid. Preferably, the wings 98 include barbed feet 94 adapted to engage with a flange 96 of the base element 60 (Figure 6). The barbed feet 94 are generally configured to fix the introduction cover to the disk 60 of the base element. The height 'h' between the upper part of the barbed feet 94 and the bottom of the tubular wall 86 of the coupling part 74 of the access point is generally selected to correspond to the dimensions of the base element 60 in order to provide a secure fit between assemblies 20 and 30 as will be described below. In an alternative embodiment, the barbed feet 94 may be omitted, and the introduction cover may be maintained in an operative position with respect to the base assembly 20 by other means. For example, the access point 62 and the coupling part 74 of the access point can alternatively be threaded such that the introduction cover can be screwed onto the base element.

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In the illustrated embodiment, the introduction cover 64 is generally circular as seen from above (see Figure 2). As shown in Fig. 2, a pair of release handles 100 are provided on opposite sides of the circular cover 64 in the area of the barbed leg 94 to allow the introduction cover 64 to be released from the coupling with the element of base by applying a force on the arrows 102, preferably by pressing the release handles 100 between the thumb and middle finger. In the embodiments illustrated in Figures 2-4 and 8, the release handles 100 comprise vertically extending parts that can be integrally formed with the dome-shaped part of the introduction cover 64. Alternatively, the vertically extending portions can be separate sections that can be made separately from the introduction lid and secured thereto by any appropriate method. In operation, the application of a force on the arrows 102 will create a bending moment at the intersection of the vertically extending part and the dome-shaped lid. This bending moment will cause the wing sections 98 of the introduction cover 64 to bend radially outward, thereby releasing the feet 94 of coupling spikes with the base element 60.

In alternative embodiments, the release handles 100 may include convex protuberances, concave recesses, or other shapes to allow the shape of the introduction cover to deform to facilitate removal of the introduction cover 64 from the base element 60. The illustrated release handles 100 advantageously allow the user to grasp the introductory cover 30 with their fingers without simultaneously grasping the flange 96 of the base element 60, facilitating the release of the introduction cover 64 of the base element 60. Alternatively, a separate tool can also be used to hold an introductory cover 64 and / or an infusion cover 54 during assembly or disassembly of a cover with the base element 60.

The introduction cover 64 is preferably injection molded from a plastic material suitable for use in medical applications. In one embodiment, the introduction cover 64 is made of a biocompatible ABS, and has a wall thickness 't' of approximately 0.030 "+/- 0.005". In alternative embodiments, the introduction cap 64 may be made of other biocompatible materials such as polycarbonate in any appropriate size as desired.

As shown in Fig. 3, the introduction cover 64 may also include ribs 104 that extend radially from the tubular wall 86 of the portion 74 of the coupling access point. The ribs 104 may be provided in any size and number as desired to provide additional rigidity to the joint between the tubular wall and the body of the insertion cover.

Embodiments of the base assembly 20 will now be described with reference to Figures 1, 5 and 6. In the illustrated embodiments, the base assembly 20 comprises a base element 60 with an access point 62 extending upwardly from the same and a soft cannula 52 extending downward from the disk 60. In the illustrated embodiments, the base element 60 is shown as a substantially circular disk; however, in alternative embodiments, the disk may have other shapes such as an ellipse, a polygon, etc. A circular base element 60 as shown, provides the advantage of allowing an introduction cover 64 and / or an infusion cover 54 attached thereto to rotate about the central axis of the base element 60.

The illustrated base element 60 comprises a flange 96 that surrounds the disk-shaped base element 60. The flange 96 is generally configured to receive the barbed feet of an introduction cover 64 and / or an infusion cover 54 to retain the cover element (64 or 54) on the base element 60. As seen in Figure 6, the flange 96 of the base element 60 may include a notched part 110 to provide clearance for the barbed feet 94. The flange 96 may also be provided with an inclined edge 112 to facilitate the assembly of the cover elements 54 and 64 with the base element 60 when the cover is pressed axially down on the base element 60 as will be described further below. .

With particular reference to Figure 6, an embodiment of the base element 60 is adapted to have a substantially low profile. For example, in some embodiment, the total height, 'q' may be between about 0.15 "and about 0.25". In a preferred embodiment, the total height 'q' of the base element 60 is approximately 0.20 ".

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According to one embodiment, the distance d between the lower surface of the flange 96 and the upper surface 92 of the base element 60 is selected to correspond to the height 'h' between the upper edge of the barbed feet 94 and the lower edge from the tubular wall 86 of the coupling part to the access point of the introduction cover 64 (as discussed above with reference to Figure 3) and the infusion cover 54 (as discussed below with reference to Figure eleven). In one embodiment, the dimensions 'd' and 'h' are substantially the same, thus providing a substantially rigid connection between a cover (64 or 54) and the base element 60. Alternatively, the "h" dimension can be made larger than the ‘d’ dimension to provide a looser connection between a cover (64

or 54) and the base element 60.

Certain advantages arise from loose or tight connections between the base element 60 and a cover element (64 or 54). For example, a tight connection between the base element 60 and the introduction cap 64 will help control the needle 66 during insertion of the needle 66 and the soft cannula 52 through the patient's skin. On the other hand, a loose but secure connection between the base element and the infusion cover 54 will allow the infusion cover 54 to rotate and move around the base element without transmitting substantial torsional tension to the base element 60 and the patient. .

As illustrated in Figure 6, the base element 60 comprises a fluid path extending from the upper part 114 of the access point 62 through the soft cannula 52 extending from the lower surface 118 of the element 60 of base. The central part of the fluid path preferably comprises a funnel-shaped section 120 with a tubular bottom section 122. According to one embodiment, a funnel-shaped insert 124 can be provided to align the inner surface of the funnel-shaped section 120. The insert 124 is preferably made of a rigid material, such as a metal, to protect the wall of the funnel-shaped section 120 during insertion of the insertion needle 66 (Figures 1 and 3). The insert 124 prevents the funnel-shaped section 120 wall from scratching and / or causing the wall fragments to separate and enter the infusion stream.

The soft cannula 52 extending from the base element 60 may comprise any material recognized as suitable for use in implantable fluid-bearing lumens within a patient's body. Infusion kits can be offered with soft cannulas that have a variety of lengths to accommodate differences in the desired depth to which the cannula extends within a patient. As the person skilled in the art will understand, in many embodiments the soft cannula 52 preferably extends into a subcutaneous fat layer of a patient. Therefore, cannulas of various lengths are useful to allow a variety of different patients with more or less subcutaneous fat to use the infusion set present. For example, soft cannulas can be produced in lengths from about ¼ "to about 2". Depending on the intended use, soft cannulas with lengths outside this range can also be used.

Figures 1, 5 and 6 illustrate embodiments in which the cannula 52 extends from the lower surface 118 of the base element 60 at a substantially right angle. In alternative embodiments, cannula 52 can be configured to extend from the base element at an angle substantially less than 90 °.

In alternative embodiments, the soft cannula 52 could be replaced by a substantially hard cannula or hypodermic needle as desired. Said cannula or hard needle could also be provided at any angle relative to the lower surface 118 of the base element 60 as desired.

In one embodiment, the soft cannula 52 can be attached to the funnel-shaped insert 124 and the funnel cannula assembly can be inserted into the funnel-shaped section 122 of the base element 60. In an alternative embodiment, the soft cannula 52 can be fixed directly to the base element to extend from the bottom surface 118 of the base element 60 on an inner or outer surface of the tubular bottom section 122 of the funnel-shaped part such as is desired.

As shown in Figures 1, 5 and 6, the access point 62 extending from the base element 60 preferably comprises a self-sealing partition 130 located in the cavity 132 above the funnel-shaped section 120 of point 62 of access. The partition 130 is preferably located at or near the top of the access point 62 to present an easily accessible surface for antiseptic washing to keep the partition 130 free of bacteria and other debris. The positioning of the partition above the funnel-shaped section 120 helps keep the section 120 in the form of a sterile funnel. In the illustrated embodiment, the partition 130 preferably comprises a groove 134 that forms a fluid path through the partition 130. Although the groove 134 illustrated is in the form of a straight line, in alternative embodiments, the groove 134 may be circular, with cross shape or otherwise shaped to provide a scalable fluid path through septum 130. In other alternative embodiments, a preformed slit 134 may be omitted and septum 130 may be pierced with a needle or other sharp object to create a path of fluid through partition 130.

In order to create a self-sealing fluid path, the partition 114 is generally made of a substantially elastic material pushed into a sealed position. In one embodiment, the partition 114 is made of a molded disk of silicon, polyurethane or other suitable material that can be secured to the access point 62. The fixing of the partition 114 to the access point 62 can be done by any adhesive, bonding or other suitable fixing process, such as heat sealing, sonic welding, etc. In alternative embodiments, a suitable resilient material such as silicone, polyurethane or other suitable elastomeric material can be molded into the cavity 132 at the top of the access point 62 (see Figure 6). In other additional embodiments, partition 114 may be replaced by any of a variety of mechanical check valves or other seals configured to provide a resealable fluid path. In another embodiment, the partition 114 and the body of the base element 60 may be integrally formed from the same substantially elastic material.

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According to one embodiment, as illustrated for example in Figure 8, the partition 114 is a molded disk of a substantially elastic material that is retained at the access point 62 by heat sealing. As shown, a part of a wall 136 of the access point that extends above the partition 114 and surrounds the cavity 132 where the partition 11 is located is provided. The access wall 136 is thermally sealed by slightly heating the material of the wall 136 at a temperature below its melting temperature, but high enough to soften the wall material. Once the material of the wall 136 of the access point has been softened, it can be deformed radially inwardly to catch the partition 114 in the cavity 132 of the action point 62. The thermal sealing procedure can be performed uniformly around the wall. circumference of the point, or at intervals around the wall 136. The person skilled in the art will recognize that alternative methods can also be used to secure the partition within the cavity 132, such as joint, weld, etc., as described above. .

As shown in Figure 6, the bottom tubular part 122 of the funnel-shaped section 120 is surrounded by an annular space 138 configured to allow a needle guard 140 to be fixed to the funnel-shaped section 120 (see Figures 8 and 9). In the embodiments illustrated in Figures 7 and 8, the needle shield 140 comprises a tube section of sufficient length and stiffness so that the shield 140 does not expose the sharp point of the needle. The needle shield 140 may comprise any suitable material and / or design as desired. For example, in one embodiment, the needle shield 140 comprises a section 144 of a vinyl tube that extends approximately 1/8 "to approximately 1/2" beyond the tip of the needle in the mounted position shown in the Figure 8. In alternative embodiments, the annular space 138 may be omitted and the needle guard 140 may be retained on the needle 66 by some other means, such as by a more tight friction fit around the needle 66 or providing protection of the needle as part of the packaging for the infusion assembly. In some embodiments, as illustrated in Figures 3 and 4, the needle shield 140 can be configured to be attached directly to the insertion cover 64 in order to extend at least a distance 146 between approximately 1/16 " and approximately 1/8 "or beyond the tip of the needle. In an alternative embodiment, a needle shield can be provided to fix the barbed feet 94 of the introduction cover 64 after the introduction cover 64 of the base element 60 has been removed.

If desired, the annular space 138 of the base element 60 may be provided with annular rings 142 to aid in the release of the base element from a mold half during an injection molding process. As will be apparent to one skilled in the art, it is often desirable that an injection molded part remain temporarily held in one of the halves of an injection mold until half of the mold moves to a place on a dropping bucket, moment in which the piece can be expelled from the mold by the ejector pins. In the absence of annular rings 142, an injection molded base element 60 may fall prematurely from the mold. It should be noted that the base element 60 does not need to be manufactured by injection molding, and could be done by any number of other suitable procedures, in which case the annular rings 142 could be excluded.

According to one embodiment, an adhesive layer 50 such as that illustrated in Figure 1 can be secured to the bottom surface of the base element 60. The adhesive layer 50 is generally provided to allow the base member 60 to adhere to the skin of a patient as will be described in more detail below. The adhesive layer 50 is typically provided with a backing layer support 150 to protect the adhesive side 152 of the adhesive layer 50 from dirt, dust and other contaminants that can reduce the ability of the adhesive side 152 to adhere securely to the a patient's skin and may increase the risk of infection at the injection site. The adhesive layer 50 can be fixed to the bottom surface 18 of the base element 60 by any substance

or proper bonding process. For example, the adhesive layer may adhere to the base element with a glue or other bonding agent. Alternatively, the adhesive layer 50 can be attached to the base element 60 by heat sealing, sonic welding or any other suitable process. Alternatively, the function of adhering the base element 60 to a patient's skin can be performed by other means known to those skilled in the art.

Figures 7-9 illustrate an embodiment of an introduction assembly 30 attached to a base assembly 20. As shown, the introduction cover 64 is preferably connected to the base element 60 by coupling the barbed feet 94 with the flange 96 of the base element 60. By detachably attaching the introduction cap to the base element 60, the needle 66 is temporarily secured within the cannula 52 to provide a rigid puncture surface during the process of inserting the cannula 52 into the patient's body. If the insertion cover 64 or the needle 66 were not coupled with the base element 60, then the introduction cover 64 and the base element 60 could be separated or misaligned during insertion into the patient, which may involve repeated perforation and causing pain. unnecessary and discomfort to the patient. In the illustrated embodiment, the coupling of the introduction cover 64 and the base element 60 allow these components to be pressed together against the patient, preferably with a single rapid movement. The cylindrical wall 86 of the coupling part 74 of the access point is also preferably coupled to the upper surface 92 of the base element 60.

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The coupling portion 86 to the access point of the introduction cover 64 is preferably adapted to surround the access point 62 of the base element 60. This provides a tight fit between the introduction cover 64 and the base element. This narrow adjustment can help prevent the base element from oscillating or making another unwanted movement in relation to the introduction cover 64. These same advantages can also be beneficial in the context of infusion cap 54, as will be described further below. In one embodiment, the inside diameter of the access point coupling portion 74 is approximately 0.025 "to approximately 0.1" greater than the access point 62 of the base element 60. Depending on the desired application, in alternative embodiments, the inner diameter may be outside this range.

With reference to Figures 10-14, embodiments of infusion assemblies 40 adapted to be mounted on the base element 60 will now be described. As illustrated, an infusion cover 54 may be configured to be fixed to a base element 60 in a manner similar to that of the introduction covers 64 discussed above.

With reference to Figure 11, an embodiment of the infusion cover 54 is adapted to have a substantially low profile. For example, in some embodiment, the total height, 's' may be between about 0.300 "and about 0.400". In a preferred embodiment, the total height 's' of the infusion cover 54 is approximately 0.335 ".

In one embodiment, an infusion cap 54 comprises a tube receiving lumen 160. The tube receiving lumen 160 is generally configured to accept a flexible tube section 162 with an internal lumen 164 as shown in Figure 11. The tube receiving lumen 160 may comprise any appropriate cross-section (for example, as see in the axial direction) as desired, but will generally have an axial cross section corresponding to an axial cross section of the selected tube 162.

The tube 162 generally comprises a circular cross section with a diameter between about 0.030 "and about 0.10". The tube can be of any material suitable for use in the transmission of fluids in medical applications. Generally, the tube will be made of medical grade polyethylene or polyvinyl chloride, although other materials may be used alternatively. The end of the tube 162 that is opposite the infusion cap may be provided with a connector for joining the tube in fluid communication with the outlet of a pump or other fluid source. For example, in one embodiment, the opposite end of the tube 162 comprises a Luer lock connector. Alternatively, other connectors may be used as will be understood by one skilled in the art in view of the present description.

The tube 162 can be fixed to the infusion cover 54 by any suitable process or mechanism as desired. For example, in the illustrated embodiment, the tube receiving lumen 160 narrows in diameter from the outer end 166 to the inner end 168. This taper provides tight pressure adjustment, allowing the tube to be retained by friction between the inner wall of the tube receiving lumen 160 and the outer wall of the tube 162. If desired, the tube 162 can be additionally secured in the receiving lumen of tubes by adhesives, sonic welding, heat sealing or any other suitable procedure.

As can be seen in Figures 11, 13 and 14, the infusion cover 54 may further comprise a hard cannula 170 with a lumen 172 configured to be in fluid communication with the tube 162. The hard cannula 170 can be integrally molded as part of the infusion cover 54, or can be subsequently joined by any suitable procedure. The inner diameter of lumen 172 of the hard cannula will generally be selected to allow sufficient fluid flow through it. For example, in some embodiments, lumen 172 has an internal diameter of between about 0.01 "and about 0.03" and, in one embodiment, lumen 172 has an internal diameter of about 0.02 ". Other diameters outside these ranges may alternatively be used as desired.

In the embodiment of Figure 9, the hard cannula 170 is surrounded by a cylindrical wall 86 to protect the cannula 170 from contact with the fingers of a user or other objects that can contaminate the lumen sterility. The hard cannula 170 can be placed inside the cylindrical wall 86 such that the cannula is substantially coaxial with the cylinder wall 86, thereby providing an automatic alignment of the cannula with the exact center of the partition 130 when the wall 86 of the cylinder is coupled to access point 62. As described with reference to the previous introduction cover 64, the cylindrical wall 86 of the infusion cover 54 is preferably sized and configured to provide a substantially closed fit with the access point 62 of the base element 60. Providing a close fit advantageously helps the alignment of the hard cannula 170 with the access point. The close adjustment also advantageously causes any force to be applied to the infusion cap 54, such as the tapping cap or the tube 162 being pulled, will be applied at the intersection of the access point and the coupling part 74 with the access point instead of the barbed feet (which could cause the infusion cap to be disconnected from the base element 60).

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The hard cannula 170 is generally configured to extend through at least a portion of the partition 130 when the infusion cover 54 and the base element 60 are assembled. Thus, the hard cannula 170 is generally sized such that it extends within the coupling part 74 of the access point a sufficient distance so that when the wall of the coupling part of the contact point contacts with the upper surface 92 of the base element 60, the hard cannula 170 will extend to at least a part of the partition

130. Thus, the dimension 'e' between the outlet 174 of the hard cannula 170 and the lower edge 182 of the coupling part 74 of the access point is preferably smaller than the dimension 'j' between the upper surface 92 of the base element and the bottom of the cavity 132 at the access point 64 (see Figure 5). In alternative embodiments, the ‘e’ dimension may be equal to or larger than the ‘e’ dimension if it is desirable for the hard cannula 170 to extend only partially through the partition 130, for example. In a preferred embodiment, as illustrated in Figure 11, the hard cannula 170 extends completely through the partition 130.

The hard cannula 170 also preferably has a sufficient column strength to be inserted through the partition 130 (or other sealing element). Thus, the hard cannula 170 is generally made of a rigid material such as PVC, PET, nylon, stainless steel or other material suitable for use in medical applications and having sufficient rigidity.

Similar to the introduction cover 64, the infusion cover 54 also preferably comprises release handles 100 that can be compressed to release the coupling cover from the base element 60. In the embodiment illustrated in FIGS. 10, the release handles 100 are shown as convex segments in grooves located approximately 90 ° from wings 98 and barbed feet 94. The release handles 100 can be coupled by the fingers of a user to release the coupling cover 54 or 64 with the base element 60. By pressing the release handles 100, the circular shape of the cover 64 deforms in an elliptical shape with the barbed feet 94 along the major axis of the ellipse. Thus, pressing the cover 64 on the release handles 100 causes the barbed feet to move radially outward and away from the edges of the base element 60, thereby releasing the cover 64 from the base element 60. In alternative embodiments, the release handles 100 of the introduction cover 54 and / or the release handles 100 of the infusion cover 54 may comprise smooth convex sections, concave sections or any of a variety of other shapes.

The methods of using the infusion equipment embodiments described above will now be described with continuous reference to Figures 1-11. In preparation for the introduction of infusion equipment into a patient, the base assembly 20 and the introduction assembly 30 will generally be assembled as shown in Figures 6 and 7. In some embodiments, the base assembly 20 and the introduction assembly 30 can be provided to an end user in a pre-assembled condition. Alternatively, in other embodiments, the parts may be provided separately for assembly by an end user.

According to one embodiment, a patient will follow these steps in order to introduce the soft cannula 52 and connect the infusion set. The patient can remove the needle shield 140 from the position shown in Figure 7 by grasping the needle shield 140 and pulling it axially from the insertion cap 64, thereby exposing the insertion needle 66 and the soft cannula 52 which is extends from the lower side 118 of the cover of the base element 60.

The support layer 150 can then be removed from the adhesive layer 50, thereby exposing the "sticky" side of the adhesive layer to adhere to the patient's skin. While the introduction cap 64 is squeezed in any desirable manner, or using any suitable tool, the insertion needle 66 and the soft cannula 52 are quickly pressed against the patient's skin and inserted through the patient's subdermal tissue until the Adhesive layer 50 contacts the patient's skin and adheres to it. The adhesive layer 50 is preferably substantially free of creases or "bubbles", thereby forming a close and secure bond.

Once the needle 66 and the soft cannula 52 have been inserted to the desired depth, the introduction cap 64 can be removed from the base element 60 and the patient. In order to remove the introductory cover 64 from the base element 60, the release handles 100 can be engaged by the fingers of a user and compressed, thereby deforming the circular cover and causing the barbed feet 94 to be released from the coupling with the flange 96 of the base element 60. In alternative embodiments, the release handles 100 may be compressed by a supplementary tool. In other alternative embodiments, the introduction cover 64 can be configured so that the release handles are handled in another way (eg, twisted, separated, etc.) to remove the introduction cover 64 from the base element. In further embodiments, the barbed feet 94 may be omitted, as discussed above, or replaced with a suitable alternative structure, thus allowing a user to simply pull out the infusion cap 64 to remove the needle.

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66.

Once the insertion cover 64 is disengaged from the base element 60, the cover is pulled out and away from the patient, and the needle 66 is removed from the soft cannula 52. The soft cannula remains within the patient, extending to a desired depth within the subdermal tissue of the patient and is held in place by the base element 60 and the adhesive layer 50. As described above, the partition 130 is generally configured to seal the fluid path when the needle 66 is removed, thus preventing unwanted flow of fluids or contaminants through the cannula 52.

Once the base element 60 and the cannula 52 are in place, the infusion cover 54 can be attached to the base element 60, thereby placing the lumen 164 of the infusion tube 162 in fluid communication with the cannula 52 soft As the user assembles the infusion cover 54 with the base element 60, the coupling part 74 will surround the access point 62, thereby aligning the hard cannula 170 of the infusion cover 54 with the slit 134 in the partition 130. As mentioned above, the slit can be preformed or a hole can be formed by the needle 66 extending through the partition 130. The automatic alignment of the hard cannula with the slit 134 of the partition allows simple assembly and a decreased risk of misalignment. This is particularly advantageous for diabetic patients who often have impaired vision.

The infusion cover 54 can be pressed against the base element until the barbed feet 94 "fit" into the coupling with the flange 96 of the base element. In one embodiment, the infusion cover 54 can be configured to create a "pressurized" audible sound when pressed on the base element 60 to allow a user to audibly and / or tactilely verify the complete coupling of the infusion cover 54 on the base element 60.

There are many circumstances, such as when the patient bathes, sleeps, sports, etc., when it is desirable to disconnect the infusion set without removing the cannula from the patient's body. When the infusion set is disconnected, the base element is exposed to potential contamination by dust, dirt, bacteria and other contaminants. In addition, the possibility of the base element being hooked or stretched by clothing or other objects poses potential problems. As will be clear to the person skilled in the art in view of the present description, these and other issues are addressed by the advantageous features of the infusion equipment embodiments shown and described in this document.

The infusion set illustrated provides repeated disconnection and reconnection of the infusion cover 54 to and from the base element 60. The infusion cover 54 can be removed from the base element 60 by applying a force to the release handles 100 to cause the barbed feet 94 to disengage from the flange 96 of the base element 60. Similar to the introduction cover 64, the infusion cover 54 can be coupled by the fingers of a user or any other suitable tool or device to facilitate removal of the cover of the base element 60.

The infusion equipment embodiments described herein provide a single fluid path through the base element allowing the hard cannula 170 of the infusion cap 54 to extend through the same path of the base element as the needle 66 of the cover 64 of introduction. This arrangement advantageously reduces the number of possible points of contamination within the infusion system. When the infusion cover 54 is removed, the partition 130 will seal the fluid path to prevent unwanted blood flow and prevent unwanted particles and fluids from entering the patient through the cannula 52.

As mentioned above, the base element 60 and the cannula 52 may be left in place within a patient for a few days or more, and in some circumstances, the base element may be left disconnected from the infusion cap for a period. of a few hours or more. The illustrated base element 60 has an advantageously low profile, thereby reducing the likelihood that the base element 60 will "catch" on clothing, towels or other objects when the patient bathes, dresses, etc. The dome-shaped infusion cap of the above embodiments also advantageously covers the entire base element, thereby protecting the base element against contamination by dirt, dust, germs or other contaminants. The low profile of the base element 60 and the substantially flat upper surface of the partition 130 are advantageously free of cavities or cracks that could contain contaminants. In addition, the low profile design decreases the likelihood of a patient hitting or pushing the infusion set inadvertently during use, causing discomfort and / or requiring repositioning or replacement of the infusion set.

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In addition, the position of the partition 130 on a distal surface of the base element relative to the patient's body advantageously provides a simplified cleaning of the partition. As shown and described above, partition 130 is preferably positioned so that it is flush with the upper edge of access point 62. This provides easy cleaning of the partition 130 and the access point 62, such as with a cotton swab and alcohol, or any other cleaning product suitable for use in medical applications.

In other circumstances, it is desirable that the infusion set has a substantial freedom of movement while it is installed and mounted. For example, once assembled, the embodiment of an infusion set illustrated in Figure 12 has the advantage that the infusion cover 54 can rotate relative to the base element about an axis perpendicular to the plane of the lower surface 118 of the base element and extending through the center of access point 62. Said rotation advantageously allows a patient to move the tube 162 to the front or rear of the patient's body without inducing a torque on the base element 60. Thus, an infusion set having an infusion cap that is capable of rotating around a central axis of a base element while maintaining fluid communication between a pump and a patient's body has the visible advantage of provide the patient with substantial freedom to position the infusion tube 162 in any radial position with respect to the base element.

The end of the tube 162 in front of the infusion cap can be connected to a suitable pump or other fluid source before or after the assembly of the infusion cap 54 and the base element 60. In alternative embodiments, an infusion system may comprise additional tubes, connectors or other components between the soft cannula and a fluid source.

In alternative embodiments, the base element 60 shown and described herein may be used to deliver medications or other therapeutic fluids to a patient without the use of the other elements of the infusion set described herein. For example, a base element such as those described above could be used in combination with a standard hypodermic syringe to deliver a therapeutic fluid to a patient by extending a syringe cannula through the septum and injecting the fluid through the soft cannula of the base and in the patient.

Although certain embodiments and examples have been described herein, those skilled in the art will understand that many aspects of the methods and devices shown and described in the present description can be combined and / or modified differently to form other additional embodiments. For example, any component of the infusion set shown and described above can be used alone or with other components. Additionally, it will be recognized that the methods described herein can be practiced in different sequences, and / or with additional devices as desired. Such alternative embodiments and / or uses of the methods and devices described above and the obvious and equivalent modifications thereof are intended to be included within the scope of the present invention. Therefore, it is intended that the scope of the present invention is not limited by the particular embodiments described above, but should be determined only by a fair reading of the following claims.

Claims (13)

image 1 1. An infusion set comprising: a base (60) having upper and lower sides (92, 118), a base cannula (52) extending downward from the lower side (118), a flange (96) and an access point (62 ) extending upward from the upper side (92), the access point (62) being in fluid communication with the base cannula (52), and the access point (62) comprising a partition (130) adapted to seal the lateral access point (62) from the fluid communication therethrough; an adhesive layer (50) mounted on the lower side (118) of the base (60); an introduction cover (64) adapted to be pressed against the upper side (92) of the base (60) and detachably fixed to the base (6), the introduction cover (64) comprising the upper and lower sides and a needle (66) extending downward from the lower side, the needle (66) being adapted to extend through the septum (130) on the upper side of the base (60) and through the cannula (52) of the base on the lower side (118) of the base (60) and an infusion cover (54) comprising an upper side and a lower side, a coupling part (74) of the access point with a tubular wall (86) and barbed feet (94) adapted to engage the flange (96) of the base (60), the infusion cover (54) being detachably detachable from the base (60), the coupling part (74) to the access point with its tubular wall (86), which closely surrounds the point of access (62) when the infusion cover (54) is connected to the base (60), the infusion cover (54) being adapted to rotate with respect to the base (60), while the cover (54) of Infusion comprises an infusion cannula (170) extending downwardly from the bottom side of the infusion cap (54), and an elongated flexible lumen (162) in fluid communication with the infusion cannula (170), being adapted the infusion cannula (170) to extend through the partition (130) on the upper side of the base (6) by attaching the infusion cover (54) and the base (60) to place the flexible lumen (162) and the infusion cover (54) in fluid communication with the base cannula (52), the wall (86) ) tubular of the coupling part (74) of the access point that surrounds and covers the end of the infusion cannula (170) with a vertical dimension (e) between an outlet (174) of the infusion cannula (170) and a lower edge (182) of the tubular wall (86) of the access point coupling part (74) and a vertical distance (h) between an upper edge of the barbed feet (94) and the edge (182) bottom of the tubular part (86) of the coupling part (74) to the access point.

2.

 The infusion set of claim 1, wherein the base (6) is generally circular.

3.

 The infusion set of any preceding claim, wherein the flange (96) surrounds the base (60).

Four.

 The infusion set of any preceding claim, wherein the infusion cover (54) includes a substantially cylindrical part (86).

5.

 The infusion set of any preceding claim, wherein the base (60) includes a funnel-shaped part (120) located between the access point (62) and the base cannula (52).

6.

 The infusion set of claim 5, wherein the funnel-shaped part (120) is located between the partition

(130) and the base cannula (52).

7.

 The infusion set of any preceding claim, wherein the base includes a funnel-shaped insert (124) located between the access point (62) and the base cannula (52).

8.

 The infusion set of claim 7, wherein the funnel-shaped insert (124) is located between the partition (130) and the base cannula (52).

9.

 The infusion set of any preceding claim, wherein the infusion cover (54) has a substantially dome-shaped low profile upper side.

10.

 The infusion set of any preceding claim, wherein the introduction cover (64) includes a part

(86) substantially cylindrical adapted to surround the access point in the base (60) when coupled thereto to help secure the cover (64) for introduction to the base (60).

eleven.

 The infusion set of any preceding claim, wherein the introduction cover (64) includes at least one generally flat surface to facilitate the grip of the introduction cover (64).

12.

 The infusion set of any preceding claim, wherein the introduction lid (64) includes at least two generally flat surfaces to facilitate the tightening of the introduction lid (64) to change its shape to allow the lid (64) to Introduction is detachably coupled with the base (60).

13.

 The infusion set of any preceding claim, wherein the infusion cover (54) includes at least two surfaces (100) that when pressed deform the infusion cover (54) in an elliptical shape with the barbed feet (94) along a main axis of the ellipse at 90 ° of said surfaces (100) to allow the infusion cover (54) to be released from the base (60).

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